Progesterone API Powder Supplier

Progesterone API Powder Supplier

Product Name:Progesterone API Powder
Appearance:White powder
CAS:57-83-0
Molecular formula:C21H30O2

Product Introduction

Chemical & Physical Specifications

Item Specification
Product Name Progesterone
CAS No. 57-83-0
IUPAC Name Pregn-4-ene-3,20-dione
Molecular Formula C₂₁H₃₀O₂
Molecular Weight 314.46 g/mol
Synonyms Corpus luteum hormone, 4-Pregnene-3,20-dione
Appearance White to off-white crystalline powder, odorless
Assay (on dried basis) 97.0% – 103.0% (USP / EP standard)
Melting Point 127 ~ 131 °C
Solubility Practically insoluble in water; soluble in ethanol, acetone, ether
Heavy Metals ≤20 ppm
Loss on Drying ≤0.5%
Related Substances Complies with pharmacopoeia limit
Storage Tightly closed, protected from light, cool dry place
Shelf Life 36 months under proper storage

 

Progesterone API Powder

 

Products Description

 

Progesterone API Powder Supplier | CAS 57-83-0, USP/EP/BP Micronized Grade

Progesterone API Powder is a bioidentical endogenous steroid hormone active pharmaceutical ingredient, CAS 57-83-0. It is chemically identical to progesterone secreted by the human ovary, corpus luteum and placenta. The material appears as white or off-white crystalline powder, practically insoluble in water, freely soluble in ethanol, methanol and other organic solvents USP29-NF24.

As a core progestogen API, progesterone regulates endometrial maturation, supports luteal phase, inhibits ovulation and maintains pregnancy. It is widely demanded by pharma factories, CDMOs, compounding pharmacies and fertility formulation manufacturers globally.

We are a professional Progesterone API powder supplier with stable GMP production control. We supply both standard crystalline progesterone and micronized progesterone grades complying with USP, EP and BP pharmacopoeia standards. Every batch is tested by in-house QC laboratory and accompanied by complete registration documents including COA, HPLC chromatogram, SDS and audit files.

 

 

COA 

 

Certificate Of Analysis

 

Product Name

Progesterone Powder

Batch No.

HZP20261102

Quantity

401.5KG

Man. Date

2026-11-03

Packaging

25KG/Drum

Test Date

2026-11-04

Expiry Date

2028-11-04

Report Date

2026-11-04

Test Items

Standard

Test Results

Characteristics

White or practically white crystalline powder, Is odorless and has a bitter taste

Complies

Identification

Complies

Complies

Solubility

Freely soluble in water,practically insoluble in alcohol,in chloroform,and in ether

Complies

Melting point

238~242℃

241.5℃

PH

3.5~5.5

4.2

Loss on drying

≤2.0%

0.3%

Related substances

Total impuritites≤2.0%

Complies

Residual solvent

Ethanol ≤5000ppm

Ethyl acetate≤5000ppm

Dichloromethane≤600ppm

Isopropanol ≤5000ppm

2733ppm

32ppm

ND

ND

Assay

98.0%~102.0%

101.0%

Conclusion

Complies with USP41 standards.

 

Mechanism of Action

Progesterone binds specifically to intracellular progesterone receptors (PR), then translocates into the nucleus to modulate gene expression in reproductive tissues.

Promotes endometrial glandular secretory transformation, preparing uterine lining for embryo implantation;

Reduces uterine smooth muscle excitability and contraction risk;

Supports corpus luteum function during early gestation;

Balances estrogen effects in hormone replacement therapy to prevent endometrial hyperplasia;

Inhibits gonadotropin release from the pituitary gland to suppress ovulation for contraceptive formulations.

Notably, progesterone belongs to BCS Class II: high permeability but very low aqueous solubility. Micronization reduces particle size and increases surface area, greatly improving dissolution rate and oral bioavailability, which is the most common upgrade for oral and vaginal dosage forms.

 

 

Key Advantages of Our Progesterone API Powder

Multiple Pharmacopoeia Grades: USP, EP, BP available for North America, EU, Middle East, Southeast Asia drug registration.

Micronized Grade Option: Controlled particle size D90 ≤10 μm, optimized for oral soft capsules, vaginal inserts and gel formulations.

Strict Impurity Control: Tight control on residual solvents, heavy metals and unknown related substances, consistent batch-to-batch quality.

Full Regulatory Document Package: COA, HPLC spectrum, SDS, GMP certificate, packing list, commercial invoice for customs and filing.

Flexible Packaging & MOQ: Trial sample order supported; bulk packaging 1kg, 5kg, 25kg fiber drum; custom labeling acceptable.

Professional Technical Support: Our team supports formulation consultation, particle size adjustment and specification customization for compounding and CDMO projects.

Stable Inventory & Flexible Shipment: Air courier for small trial lots, sea freight for large bulk orders.

Applications of Progesterone API Powder

 

Progesterone API is used for manufacturing prescription pharmaceutical finished forms and compounding preparations:

Micronized oral soft gelatin capsules for hormone replacement therapy and luteal support

Vaginal progesterone gel, suppositories and inserts for fertility / IVF luteal phase support

Oil-based injectable progesterone suspension

Topical creams and transdermal compounded preparations for compounding pharmacies

Veterinary reproductive hormone formulations

Analytical reference standard for pharmaceutical R&D and lab testing

Important Disclaimer: This product is raw pharmaceutical API only, supplied to licensed pharma manufacturers, CDMOs and qualified compounding pharmacies. Not for direct human consumption.

 

Grades & Packaging

 

Grade Particle Size Recommended Formulation Package
Standard USP/EP Crystalline Grade Normal crystal Injectable suspension, synthesis intermediate 25kg fiber drum
Micronized Progesterone Grade D90 ≤10 μm Oral capsules, vaginal gel, suppositories 1kg / 5kg / 25kg
       

Why Choose Us As Your Progesterone API Supplier

✅ Stable factory source, competitive pricing without multi-layer middleman markup

✅ Independent QC lab, every batch released only after full pharmacopoeia testing

✅ Accept third-party inspection by SGS, Eurofins or other authorized labs

✅ Export team familiar with steroid API import permit and customs requirements

✅ Confidential technical communication for compounding and formulation development

✅ Prompt after-sales service for document revision and shipment tracking

Storage & Safety Guidance

Storage: Keep container tightly sealed, away from light, moisture and high temperature; separate from strong oxidants.

Personal protection: Wear dust mask, safety goggles and chemical resistant gloves during powder handling; avoid inhalation, skin and eye contact.

First aid: In case of eye or skin contact, rinse thoroughly with plenty of clean water. Seek medical help if irritation persists.

Waste treatment: Dispose waste powder and packaging following local pharmaceutical hazardous waste regulations. Refer to SDS for complete hazard information.

Frequently Asked Questions (FAQ)

 

Q1: What is micronized progesterone API?

A: Micronized progesterone is chemically identical to standard progesterone, processed by micronization to reduce particle size. Fine particles improve dissolution and oral/vaginal absorption, widely used for Utrogestan-type vaginal and oral capsule formulations.

Q2: What pharmacopoeia versions can you supply?

A: We provide progesterone API complying with USP, EP and BP monographs. Custom internal specifications are available for special regional registration.

Q3: Can I get free samples for lab formulation test?

A: Yes, small trial samples are available for quality and dissolution testing before bulk order. Sample freight cost to be confirmed.

Q4: What documents will be provided together with shipment?

A: Commercial invoice, packing list, COA, HPLC chromatogram, SDS, GMP copy. We can prepare extra supporting files upon your registration requirement.

Q5: What is your MOQ and lead time?

A: Our MOQ is [fill your MOQ]. Stock goods can ship in 3–7 working days; bulk production order takes around 15–25 working days.

Q6: Is progesterone API a controlled steroid material?

A: Progesterone is prescription steroid API. Buyers must hold valid pharmaceutical business license and follow local import regulatory rules for hormone raw materials.

Q7: What is the difference between progesterone and progestin?

A: Progesterone is the natural bioidentical hormone. Progestins are synthetic progestogen analogues such as norethisterone, medroxyprogesterone acetate.

Request a Quote

Looking for a reliable luliconazole powder (API) supplier? Send us your required grade, quantity and destination, and we will reply with an itemized quote, COA sample and lead time. You can contact me through my contact information.
Name :Serena Pang
Mobile :15667080670
We:15667080670
Whats:+8615667080670
E-mail:Serena@xaheshun.com
Best regards,
Serena Pang
Xi'an Tongze Biotech Co., Ltd.

 

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Why choose our Hydroxychloroquine Powder?

1.AFTER SALES

Effective reshi aftersales service

2.CUSTOMIZED

Customized Labelsand packageOEM /ODM service

3.STORAGE ROOM

USA warehouse

4.PRICE

Reasonablecompetitive price

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Packaging & Shipping

 

Packaging: 25kg/bag or according to client request
Delivery Detail: 1~2 weeks after confirm order.Some of the products can be supplied within 7 days on the strength of EDC warehouse.
 

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FAQ

 

Q1: What service can you provide?

A:We can provide very competitive prices and very good service to our clients all over the world.

Q2: Can you do customized?

A:We can make the products as per customers' requested products and quantity

Q3:Can we have samples for development?

A:Yes we can provide free samples (small quantity) to you, but the freight cost on buyer's account.

Q4:What is the normal lead time?

A:1. For stock products, we will send goods to you within 2-3 days after we receive your payment.
2. For customized products, generally the delivery time is around 30 days after we receive your payment.

 

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